Rituximab to Prevent Recurrence of Proteinuria

Proteinuria Clinical Trial

Official title: The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS

Status Terminated

Clinical Trial Summary

The investigators propose to study novel targets of rituximab in podocytes, with a particular focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong clinical implications, since it may extend the approved indications for rituximab treatment to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new insights into the role of sphyngomyelin related enzymes in podocyte function in health and disease, thus allowing the identification of novel targets for antiproteinuric drug development. Finally, the proposed study offers the opportunity to identify a correlation between the patient's specific clinical outcome and the experimental results obtained after exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may lead to the development of an assay for the pre-transplant identification of patients at high-risk for recurrent disease and, among them, may allow the identification of those patients that will respond to rituximab.

Clinical Trial Description

A total of 60 patients will be enrolled in the study. ;

Related Conditions & MeSH terms

• FSGS
• Proteinuria
• Recurrence

• NCT number: NCT01164098
• Study type: Interventional
• Source: University of Miami
• Status: Terminated
• Phase: Phase 3
• Start date: February 2012
• Completion date: October 2016